Quality Assurance Manager – CMO

Numab Therapeutics AG

Aussicht: 160

Update Tag: 25-04-2024

Ort: Wädenswil Zürich ZH

Kategorie: Apotheker / Pharmavertreter

Industrie:

Jobtyp: CDI, Temps de travail : 80-100%

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Jobinhalt

Numab Therapeutics AG is an expanding, clinical stage Swiss biotech company based in Wädenswil, Kanton

Zürich. The company is focused on the discovery and development of innovative, antibody fragment-based

therapeutics with a focus on immuno-oncology. With our breakthrough antibody-discovery and multi-specifics

engineering platform, we engage in proprietary projects as well as collaborative research on behalf of partners

in the pharmaceutical industry.

To oversee, foster, and assure the quality of Numab’s contract manufacturing organizations (CMOs) and to

release product for our sponsored clinical development programs, we are looking for a

Quality Assurance Manager – CMO (80-100%)

In this position you will report to the Head Quality Assurance (QA), and you will be responsible for closely working

together with contract manufacturing organizations (CMOs) as Numab expands clinical development with novel

antibody fragment-based immuno-oncology therapies. This role drives the classic QA activities with external and

internal partners: Audits, deviations, OOS, change requests, quality agreements and validation of CMOs. This is

a key role for upholding the organization’s commitment to quality and compliance on a corporate level and

specifically in our sponsored drug manufacturing and clinical development programs.

Your Responsibilities

  • Management of all QA requirements of our CMOs
  • Liaise with subject matter experts from CMC, Preclinical, Clinical Development and Drug Safety to ensure

the organization’s compliance with applicable GMP regulations

  • Manage the QA aspects of a network of suppliers and co-development partners to ensure compliance and
project progress at required quality
  • Build and maintain the CMO quality system and related processes, and provide strategic expertise to
Numab leadership and project teams on CMO and GMP matters

Ideal candidates will have

  • Degree in the life sciences or equivalent qualification, with 5+ years of QA experience according to GMP at
a biotech/pharma organization
  • A passion for CMO management and product quality
  • Strong understanding of CMO management and underlying processes
  • Thorough knowledge of global GMP requirements for all phases of product development through

commercialization; pharmaceutical development/manufacturing of biologics as a plus

  • Experience in planning and conducting internal and external audits and regulatory agency inspections, and
negotiating and implementing quality agreements
  • Experience as responsible person (FvP) or willingness to gain such experience
  • Ability to work both independently and as part of a team
  • Fluency in English as well as strong IT and organizational skills
  • Willingness to travel 5%

Are you looking for an inspiring, entrepreneurial atmosphere and want to be part of a dynamic team where your

contributions are both essential and valued? We are looking for skilled and passionate people who are eager to

make an impact. We are offering a permanent position in an innovative environment as well as a competitive

compensation package including a participation in the company.

We are looking forward to receiving your application with reference number NB080 to hr@numab.com.

Numab Therapeutics AG | Einsiedlerstrasse 34 | CH-8820 Wädenswil | Switzerland | www.numab.com

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Frist: 09-06-2024

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